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FDA Approves Cinacalcet, First in a New Class of Drugs to Treat Hyperparathyroidism
Cinacalcet is the first drug in the class of compounds known as calcimimetics to be approved by the FDA. It is approved as a treatment for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Elevated levels of parathyroid hormone (PTH), the hallmark of secondary hyperparathyroidism, are associated with altered metabolism of calcium and phosphorus, bone pain, fractures, and an increased risk for cardiovascular death. Treatment with cinacalcet lowers serum levels of PTH as well as the calcium x phosphorus ion product. The calcium x phosphorus ion product is a measure of the amount of calcium and phosphorus in the blood, and when elevated, causes harmful deposition of calcium in various parts of the body.
Cinacalcet is also approved for the treatment of hypercalcemia associated with parathyroid carcinoma, a rare cancer that causes significant elevations in serum calcium levels. Elevated levels of serum calcium can cause mental confusion, lethargy, dehydration, nausea, vomiting, constipation, and kidney damage.
In three 6-month cinacalcet clinical trials of more than 1,000 patients with chronic kidney disease receiving dialysis, the most commonly reported side effects were nausea and vomiting, which occurred in 31 percent and 27 percent, respectively, of cinacalcet-treated patients, compared with 19 percent and 15 percent, respectively, of patients who received placebo. Treatment of patients with chronic kidney disease with cinacalcet was also associated with the development of low serum calcium levels in a significant number of patients. Frequent monitoring of patients’ calcium levels is therefore recommended in the cinacalcet labeling.
Amgen, of Thousand Oaks, Calif. will market cinacalcet by the trade name, Sensipar.
Source: The Food and Drug Administration